Sonoma issued FDA clearance for ankle fracture offering
Click Here to Manage Email Alerts
Sonoma recently announced they have received FDA 510(k) clearance for their FibuLock Nail ankle fracture fixation offering.
An intramedullary device, the FibuLock Nail is reportedly able to treat all fractures indicated for plate-based fixation while being less-invasive and allowing for anatomic ligament stabilization. The device is implanted into the fibula via an incision of under an inch in length and then stabilized via the device’s anchors.
The company is planning on introducing the FibuLock Nail in select markets during the second quarter of 2015.
"Until the FibuLock, there wasn't a device that could deliver the stability, versatility and effectiveness of plates,” stated Rick Epstein, chief executive officer of Sonoma, in a company release. “Now, our technology will allow surgeons to bring the advantages of nailing to ankle fracture patients."
Reference: http://www.sonomaorthopedics.com/